orphan drug designation

How the FDA tries to balance urgent needs against real risks when evaluating new drugs

posted on April 1, 2013 - 9:25am

Update (April 15, 2014): This story has been updated to reflect that there is now a new FDA office, the Office of Health and Constituent Affairs, whose job it is to serve as a liaison between the FDA and various outside stakeholders, including patient advocates and consumers. See Resources, below.
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